Posted on 09/03/2024 7:13:30 PM PDT by SeekAndFind
The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer.
Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product.
FDA officials said that animal testing data supported the decision.
“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 30 statement.
The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid technology (mRNA) earlier in the month.
Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data.
“The assertion rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times previously via email.
Novavax President and CEO John C. Jacobs said in a statement that the company’s vaccine showed “robust cross-reactivity against JN.1 lineage viruses” in animals.
JN.1 was displaced in the spring by KP.3 and other variants, according to sequencing performed by the U.S. Centers for Disease Control and Prevention.
The CDC estimates that KP.3 and the closely related KP.3.1.1 caused about four in 10 cases in the two weeks ending Aug. 3. The agency estimated that KP.3.1.1 became the dominant strain by the end of August.
The Pfizer and Moderna vaccines target KP.3.
FDA officials initially advised manufacturers to target JN.1 but later recommended they target KP.3.
Because Novavax’s vaccine is built on different technology, it takes longer to manufacture than the mRNA shots. Company officials told FDA advisers over the summer that they were planning to continue manufacturing a JN.1-based vaccine and believed it would perform well against KP.3 and other strains from the JN.1 lineage.
The authorization is for people aged 12 and older. People who have never received a vaccine can get two doses of Novavax’s vaccine about three weeks apart. People who have received a vaccine before can get a single dose.
The Moderna and Pfizer vaccines are available for individuals who are at least 6 months old.
The CDC is recommending vaccination for all people aged 6 months and older.
The United States ended the COVID-19 public health emergency in 2023 but extended the emergency declaration under the Public Readiness and Emergency Preparedness Act until the end of 2024. The FDA issued the emergency authorization under that authority.
COVID-19 levels have plummeted since early 2022, although data from wastewater and other sources have indicated a recent uptick.
Twenty-eight states are reporting high levels of COVID-19 and two states are reporting very high levels, based on wastewater, according to the CDC. Hospitalizations and deaths attributed to COVID-19 have also been climbing, although the numbers are far lower than the highs recorded in 2021 and 2022.
(For what?)
To frighten the masses back into submission.
Follow the money. It’s ALWAYS about money. The US government is no longer “for the people.” It’s about lining the pockets of individuals at the expense of American health. One only need to look at pharma, sugar, and other areas to see this is playing out.
IMO, these people are just doubling down on their criminal activities. Testing? We don’t need no testing. We gots vague information on animals. It’s different technology than those old shots.
Big Pharma gets paid whether the vaccine is used or not.
Big pharma and politicians. Just great together. I will never have anything shot into me that’s recommended by the FDA since covid. AT one time, long ago they were a useful agency. Now, just a bunch of government stooges.
Post; ping; posts. BUMP! Murder home and abroad. Population reduction goes on. Comply or face consequences. Evildoers face no consequences.
Why not just hand out fentanyl to all that vax believers... No need to call it a covid 19 vaccine and probably more effective.
wow. they aren’t even pretending anymore.
they’re gonna jab as many people as they can with the toxic sh*t as quick as possible before Trump gets back in.
Flat out bought.
Oh, still EUA! In other words no recourse when you suffer deleterious side effects.
🤔🔬😵🚫😷💉💊🐂💨💩.
“that meets the FDA’s standards for safety, effectiveness...”
Well, we already know those standards don’t require any safety or effectiveness at all.
(From the article) : ” The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax,
giving Americans an alternative to shots from Moderna and Pfizer.” (Emphasis theirs)
”Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product. “
”FDA officials said that animal testing data supported the decision. “ (Emphasis theirs)
“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality
needed to support emergency use authorization,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research,
said in an Aug. 30 statement.”
”The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid technology (mRNA) earlier in the month.”
”Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data. “ (Emphasis theirs)
(THe article continues ...)
They haven’t (a) helped their buddies in the medical/pharmaceutical industrial complex make enough money yet and (b) killed/disabled enough Americans yet.
They can go vax themselves to death, the sooner the better.
There.
Fixed.
Not a problem. At least not for me. I don’t take any shots recommended by the CDC.
Rules are only for those who cannot afford bribery.
LOL! Hilarious!
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